Clinical trial · Observational
Clinically Actionable Tumor-Associated Antigens in Prostate Cancer
Expression Profiles And Prognostic Implications Of Clinically Actionable Tumor-Associated Antigens Across Diverse Clinicopathological Subtypes of Prostate Cancer: a Bidirectional Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to evaluate and validate the expression and prognostic value of 15 ADC-targetable membrane proteins (PSMA, B7-H3, STEAP1, TROP2, KLK2, HER2, TF, HER3, DLL3, SEZ6, STEAP2, MUC1, NECTIN4, FAP, PDL1) in patients with diverse clinicopathological subtypes of prostate cancer (e.g. primary and different metastatic types，HSPC and CRPC， PC with neuroendocrine differentiation, cribriform/intraductal carcinoma). The main questions it aims to answer are: 1. What is the expression profile of 15 clinically actionable targes in tumor tissues from patients with diverse clinicopathological subtypes of prostate cancer? 2. Can the prognostic value of these targets (e.g. association with overall survival) identified in a retrospective cohort be validated in an independent prospective cohort? Researchers will head-to-head compare the expression levels among different targets and across different disease stages/metastatic site. Researchers will also assess whether the targets showing prognostic significance in the retrospective cohort can also predict survival outcomes in the prospective cohort. Participants in the retrospective cohort have already provided archived tissue samples and clinical data. Participants in the prospective cohort (metastatic prostate cancer patients) will be invited to provide residual tumor tissue samples obtained during standard care and will be followed up regularly for clinical outcomes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Prostate Cancer (mCRPC) | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunohistochemistry (IHC) Staining and Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Primary Tumor Cohort
- description
- This retrospective cohort consists of patients with prostate cancer (encompassing castration-sensitive \[CSPC\], castration-resistant \[CRPC\] disease states, and those with special clinicopathological subtypes) for whom primary tumor tissue (from biopsy or radical prostatectomy) is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered.
- interventionNames
- Other: Immunohistochemistry (IHC) Staining and Analysis
- label
- Lymph Node Metastasis Cohort
- description
- This retrospective cohort consists of patients with prostate cancer (encompassing CSPC, CRPC disease states, and those with special clinicopathological subtypes) for whom lymph node metastasis tissue is available. Archived FFPE specimens were obtained at Peking University First Hospital between 2000 and 2025. This is an observational cohort. No study intervention is administered.
- interventionNames
- Other: Immunohistochemistry (IHC) Staining and Analysis
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * For the Retrospective Cohorts (mCRPC, CSPC, Special Pathology): 1. Patients with a pathological diagnosis of prostate cancer. 2. Treated at Peking University First Hospital between January 2000 and 2025. 3. Availability of adequate, qualified formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks for research. 4. Availability of essential clinical and follow-up data in medical records. * For the Prospective Cohort: 1. Age ≥ 18 years. 2. CSPC, primarily includes patients who underwent neoadjuvant therapy and have paired pre- and post-treatment biopsy and surgical specimens; or patients with special clinicopathological subtypes. 3. metastatic prostate cancer patients. 4. Planned or recent (within 6 months prior to enrollment) acquisition of tumor tissue (from metastasis or primary site) as part of standard clinical care, with sufficient residual tissue available for the study. 5. Willing and able to provide written informed consent. Exclusion Criteria: * For All Cohorts: 1. Tumor tissue sample is of insufficient quality or quantity for immunohistochemical (IHC) analysis. 2. Essential clinical or outcome data are missing or irretrievable, which would preclude meaningful analysis. * Specifically for the Prospective Cohort: 1. Any condition that, in the investigator's judgment, would significantly compromise the patient's ability to provide informed consent or comply with the study follow-up procedures. 2. Patient refusal to participate.
References
Publications (0)
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